Monitoring patients with abdominal aortic aneurysms before and after surgery

Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair

This study is trying to see how well a new imaging technology works for monitoring patients with abdominal aortic aneurysms before and after they have surgery.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ViTAA Medical Solutions (industry)
• Locations: 8 sites (Birmingham, Alabama and 7 other locations)
• Trial ID: NCT05004051 on ClinicalTrials.gov

What this trial studies

This observational registry collects imaging and clinical data from patients with abdominal aortic aneurysms undergoing endovascular repair and those in a serial monitoring program. The study utilizes ViTAA aortic mapping technology to assess patients at multiple centers across the US and Canada. Participants include those scheduled for endovascular repair and those who do not yet meet the criteria for surgery but require ongoing monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with infrarenal aortic aneurysms measuring 45 mm or more in diameter.

Not a fit: Patients with major connective tissue disorders, renal failure, or previous aortic reconstruction in the involved segment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management and outcomes of patients with abdominal aortic aneurysms through improved monitoring techniques.

How similar studies have performed: Other studies utilizing registry approaches for monitoring aortic aneurysms have shown promise, indicating potential for success in this study as well.

Eligibility criteria

Inclusion Criteria:

1. Patient is aged 18 years or over
2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.
3. Patient meets on-IFU criteria for endovascular reconstruction

Exclusion Criteria:

1. Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.
2. Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg/dL or 175umol/L
3. Patients with previous aortic reconstruction in the involved segment.
4. Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).
5. Patient has a sensitivity to contrast imaging agents.
6. Patient has aortic dissection.
7. Patient has atrial fibrillation.
8. Patient has arrhythmia.

Where this trial is running

Birmingham, Alabama and 7 other locations

• UAB - University of Alabama in Birmingham Hospital — Birmingham, Alabama, United States (RECRUITING)
• MGH - Massachusetts General Hospital Fireman Vascular Center — Boston, Massachusetts, United States (RECRUITING)
• UNC - University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
• University of Washington — Seattle, Washington, United States (RECRUITING)
• UCGY - University of Calgary, Peter Lougheed Center — Calgary, Alberta, Canada (RECRUITING)
• UHN - University Health Network - Toronto General Hospital — Toronto, Ontario, Canada (RECRUITING)
• CHUM - Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (RECRUITING)
• MUHC - McGill University Health Centre — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Mark Farber — University of North Carolina, Chapel Hill
• Study coordinator: Denis Bilodeau

Conditions: Abdominal Aortic Aneurysms